Abstract
Sterility test is an essential procedure for injectable products in pharmaceutical industries. Penicillinase breaks βlactam ring of some β-lactams. The Aim of this study was the application of penicillinase in sterility test and its validation in some injectable β-lactams. Five different β-lactamswere solved in fluid Acontaining different dilutions of enzyme. Then, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillussubtilis, Clostridiumsporogenes, Candida albicans and Aspergillusniger were inoculated to fluid A separately, and antibiotic solutions were filtered. Filterswere washed with the same dilution of fluid Awithout microorganisms andput in Fluid Thioglycollate Medium (FTM) and Tryptic Soy Broth (TSB). Media were incubated 3 days for bacteria and 5 days for mold and yeast. Microorganisms grew in the presence of Ceftriaxone and Ceftazidime containing 14286 IU/ml of penicillinase. Meanwhile, Cefazolinrequired to 28571 IU/ml and 85741IU/ml of enzyme was necessary in case of Imipenem-Cilastatin. In the presence of Meropenem, microorganisms grew just after adding 3×106IU/ml enzyme in solvent washing fluid, and 2×105 IU/ml in media. Our Results showed that penicillinase can be used for sterility test of above mentioned antibiotics. Lack of this enzyme can lead to false negative Results.
Published Version
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